By Robert J. Kerwin Medical device manufacturers, importers, distributors and user facilities have long been required to report deaths, serious injuries and malfunctions that have, may have or would be likely to cause or contribute to a death or serious injury. The FDA regulation pertaining to "user facilities" provides that reports should be filed on [...]
An opinion piece by Robert J. Kerwin Senator Ron Wyden (D-Ore) and Rep. Yvette Clark (D-NY) filed today in the U.S. Senate and the U.S. House of Representatives the first federal right to repair legislation. “There is no excuse for leaving hospitals and patients stranded without necessary equipment during the most widespread pandemic to hit [...]
May 13, 2020 By Robert J. Kerwin This article is reprinted with permission of DOTmed HealthCare Business News and can be read online in its original format at: https://www.dotmed.com/news/story/51199 In April, the FBI reported a global increase in malicious cyberactivity targeting U.S. Healthcare providers, noting that the cyberactivity was exploiting fear derived from the COVID-19 [...]
IAMERS CONTINUES TO ADVOCATE AS THE FDA SERVICING DEBATE RAGES ON DESPITE THE FDA REPORT RECOMMENDING NO NEW REGULATIONS
With rumors of a possible renewed push for Congressional legislation, IAMERS president Diana Upton and general counsel Robert Kerwin attended the AAMI Annual Meeting during the first week of June 2018. Their attendance is part of IAMERS’ efforts to reduce the fear-mongering and to get out the message of independent servicers for safe patient oriented [...]
Medical device recalls reached record highs in the first three months of 2018 thanks to software complications that are likely to continue with the proliferation of high-tech devices. Read more here.
WASHINGTON — Almost no one got everything they wanted out of the Monday deal to reopen the government — except perhaps medical device companies, who managed to fend off an industry-wide excise tax before the first payments were due. The stopgap spending deal that was signed by President Trump on Monday included a two-year delay of the 2.3 percent [...]
Shortly before the summer congressional recess, the U.S. Senate passed a bipartisan bill to reauthorize the FDA user fee programs. The Senate User Fee bill followed the House bill and was approved 94-1. President Trump’s spokesperson has announced that the president will sign the bill. See the full story at DOTmed by clicking here.
George Mills, Director of Engineering for the accrediting organization, The Joint Commission, announced yesterday at the American College of Clinical Engineers (ACCE) meeting a new element of performance expected which essentially requires healthcare organizations to have on hand service manuals and technical bulletins: EP 3 provides "The organization has a library of information regarding inspection, [...]
On June 7, 2017, the U.S. House of Representatives Energy and Commerce Committee approved an amendment to the FDA Reauthorization Act of 2017 which will require the FDA to submit to the House and Senate Committees a report on how the FDA intends to ensure the quality and continued effectiveness of devices with respect to [...]